consulting

Are you a manufacturer of medical devices and need an overview or have specific questions about approval, reimbursement or testing? Do you need a quality management system according to EN ISO 13485? The complexity of regulatory requirements harbours the risk of getting lost and taking the wrong path.

BEO BERLIN helps you to define the next steps and explains what must not be overlooked.

CE

We advise you on regulatory requirements.

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QM

We assist you with the implantation or analysis of your quality management system.

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HMV

We support you in listing your medical device for reimbursement.

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Workshop

We help your team to understand and implement legal requirements.

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FDA – 510(k) Guideline for Simplification

The guideline issued by the FDA is regulatory flexibility, including a temporary waiver of the premarket notification requirements under Section 510 (k) of the Food, Drug, and Cosmetic Act.

Northern Ireland Continues Placement of CE-marked Medical Devices

The MHRA (Medicines and Healthcare products Regulatory Agency) issues new version of guideline for placing medical devices on the Northern Irish Market Guideline The United Kingdom has left the European…

Authorised Representative for Switzerland? – revHMG Amendment to the Law on Export Certificates and Confirmations

Will applications for export certificates and confirmations be possible only for economic operators based in Switzerland assuming the role of manufacturer or Authorised Representative?

News from the MDCG 2021

The MDCG has recently published helpful documents. Is your software a medical device? Is it actually a custom-made device?

HMV – When the Application Gets Lost in Translation

When the HMV Application Gets Lost in Tranlation: dealing with the first response to your application from the GKV.

UDI – In a Nutshell

Uncertainty and questions in regards to „How and where do I obtain a UDI“ have been frequently brought to us in recent months. In a short overview we will show you possible way and provide you with relevant links to for further reading.

New Standards and Standard Projects in March 2021

DIN EN ISO 8836
DIN EN ISO 3630-1 (project)
ISO/TS 37137-1:2021

Standard in Focus: DIN EN ISO 10993-18

German version of EN ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterisation of materials was published this month and replaces the version from 2009.

Rollators – Towards a Reimbursement Listing in Germany (HMV) With Only the CE Marking

It is a long path listing rollators in the HMV (for reimbursement in Germany). Look at how to use the CE marking as successfull foundation.

Electrical Medical Devices: ear Annual Statistics Notifications Must Be Submitted by 31.04.2021

Electric medical devices: The annual statistics notification for the calendar year 2020 is legally binding and must be completely recorded in the ear portal by 30.04.2021 at the latest.